SAN FRANCISCO, CA--(Marketwired - February 02, 2017) - For the last two years, Japan has been at the forefront of accelerated approval for regenerative medicine products and has seen lots of licensing and contract manufacturing deals and M&A activity. Tokyo-based Colin Lee Novick, managing director of CJ PARNTERS, surveys the landscape, discussing recent tie-ups, the affects of the recently passed 21st Century Cures Act in the U.S., and what may lie ahead.
Included in this interview are: Regeneus Ltd. (ASX: RGS)
RepliCel Life Sciences Inc. (TSX VENTURE: RP)(OTCQB: REPCF)
The Life Sciences Report: Would you talk about what is actually happening in Japan -- mergers, licensing deals, contract manufacturing tie-ups, etc.?
Colin Novick: We can classify the types of deals in Japan into three major categories. The first category is cellular manufacturing deals or contract manufacturing organization (CMO) deals. These are categorized by some of the major players in cellular manufacturing teaming up with some major Japanese corporate conglomerates that are looking to pivot into pharmaceutical manufacturing.
Very recently, a third behemoth showed up on the scene for CMOs, and that is a deal between an Australian biotech called Regeneus Ltd. and a very large Japanese corporate conglomerate called Asahi Glass Co. Ltd. (AGC). Now, the name doesn't really spell it out for you, but AGC is Japan's largest biologics CMO. AGC is basically saying it would like to expand its CMO offerings from a simple biologics manufacturing capacity to regenerative medicine.
The Regeneus deal, compared to the CMC one, is small, but for a company of Asahi Glass' caliber to come out and say, "We're going to enter into the regenerative medicine space now," is highly indicative of the potential seen by the firm in the space. It also highlights that when one looks to Japan, the usual suspects that are the pharmaceutical companies are not the only places to look; that's one thing that Regeneus was able to do…
TLSR: Okay, let's move on to licensing deals. What's going on in Japan?
CN: Back in 2013, before the Japanese regenerative medicine laws were promulgated, RepliCel Life Sciences Inc. and Shiseido Company Ltd. signed a deal for Replicel's RCH-01 product, which is for androgenic alopecia or male pattern baldness. Shiseido is taking the RCH-01 product down the Act on the Safety of Regenerative Medicine (ASRM) route to market, as they see immense market potential to offer the treatment as quickly as possible to men who suffer from pattern baldness. The ASRM route to market does not come with the coveted Japanese NHI insurance coverage, but the indication is one that doesn't necessarily need the NHI insurance coverage incentive to work.
Shiseido has already opened the Shiseido Cell-Processing and Expansion Center (SPEC) in Kobe and is using this location as its base to develop and eventually provide the therapy. Not many non-Japanese companies understand the ASRM route to market, but it is one that a relatively well-known regenerative medicine company, Cytori Therapeutics Inc., has already received multiple approvals for over the years and is a very real and relatively fast route to market that exists in Japan. I would keep my eyes peeled on RepliCel and Shiseido in the coming months, too, for indications as to when the therapy will become available in Japan…
Continue reading this interview: Companies Flocking to Japan for Biotech Deals
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Please see the end of the interview for the complete disclosure: Companies Flocking to Japan for Biotech Deals